Co-Axial Cannula Bundle - Co-Axial Cannula Bundle 17ga x 16.8cm - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Co-Axial Cannula Bundle 17ga x 16.8cm

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More Product Details

Catalog Number

MCXB1820BP

Brand Name

Co-Axial Cannula Bundle

Version/Model Number

MCXB1820BP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MJG

Product Code Name

Device, Percutaneous, Biopsy

Device Record Status

Public Device Record Key

bed93015-0ce5-4180-a017-78b80f9b9016

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Additional Identifiers

Package DI Number

20886333225891

Quantity per Package

5

Contains DI Package

00886333225897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205